Current technologies and procedures for preventing catheter related bloodstream infections are impractical, difficult and cumbersome to practice. Part of the current IV catheter patency maintenance procedure requires flushing the IV line with a pre-filled Saline (0.9% NaCl) syringe. If positive displacement connectors are not utilized blood can reflux back into the catheter and form a blood clot, which will occlude the IV line and block the catheter lumen. In addition, there are no automatic catheter connector capping systems, which are designed to protect the catheter connector after accessing the catheter and flushing the IV line.
Currently, when a connector is not being utilized, the inlet port surfaces are exposed to the environment. This allows microorganisms to populate the exposed connector inlet surfaces and enter the IV line during flushing; blood reflux can cause clot formation inside catheter lumens; microorganisms from the connector inlet surfaces can colonize blood clots inside the catheter lumens and then infect patients; and blood clots can occlude IV lines, making the lines difficult to use. In some patients, dislodged blood clots from catheter lumens could cause further complications. The recommended practices suggest cleaning the connector almost after every other step. This makes the IV maintenance process very cumbersome and it is rarely implemented.
One purpose of positive displacement valves (connectors) is to prevent blood reflux into catheters. When IV devices are being disconnected from the inlet port of valves/connectors, blood reflux can occur at the tip of the catheter. Positive displacement valves are used to prevent catheter occlusion from thrombosis or blood clot formation due to blood reflux. Some positive displacement valve manufacturers recommend saline only flushing (i.e., heparin lock flush is not needed since the valves prevent reflux). When blood is drawn through positive displacement valves, blood proteins adhere to the valve parts and can be colonized by microorganisms. The valve inlet port surfaces are potential sources for microorganisms. Positive displacement valves have mechanical parts with complex features. Therefore, it is difficult to clean the internal parts of valves by the flushing process. The FDA has raised concerns regarding CRBSI risks associated with positive displacement valves and ordered a study to address the risk.
Additionally, microorganisms from the skin can populate unprotected connector inlet port surfaces. Microorganisms from the connector inlet surfaces can be infused into the blood stream with IV solutions (e.g., during flushing). Further issues with current procedures include, but are not limited to, blood clots that get colonized by microorganisms inside catheters, inadequate or inconvenient connector cleaning practices; and complex positive displacement valve/connector parts.
There are a number of issues with current IV line maintenance and IV drug delivery practices. When catheterized patients are discharged from treatment centers, the inlet port is of the connector is exposed to the environment, and it can be populated or colonized by microorganisms. The possibility of contaminating the connector exists outside of treatment centers. Clinicians need both of their hands to clean connectors. Clinicians also need both hands to uncap a flush syringe and connect it to an IV line connector. This means after cleaning the connector, clinicians can drop the connector back on to the skin to pick up a flush syringe (i.e. two hands are needed to uncap a flush syringe and connect it to a connector).
There are also a number of issues with current IV line maintenance and IV drug delivery practices. The possibility of contaminating the connector also exists, in the period between flushing the IV line and administering therapy. Blood reflux is not prevented, unless positive displacement valves are used.
Therefore, there is a need in the art for devices and methods to protect the connector inlet surfaces from contamination, protect the flush syringe luer tip from contamination and prevent reflux to avoid blood clot formation inside catheter lumens, make the connector cleaning process convenient, consistent and intuitive for clinicians and/or flush the connector and the catheter adequately.